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Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer

Study acronym: TRIFLUOX-DP
StatusRecruiting
PhasePhase 2
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 20 to 21v8
  2. Study sites: 15 to 20v7
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2025 to Mar 21, 2025 · Site details revised at 15 of 15 sitesv6 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2025 to Mar 21, 2025
    • Site details revised at 15 of 15 sites
  4. Start date: Jan 31, 2025 to Apr 1, 2025v5
  5. Start date: Oct 20, 2024 to Jan 31, 2025 Study sites: 0 to 15v4 Show 1 more changeShow less
    • Study sites: 0 to 15
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 20, 2024 to Oct 20, 2024 Primary completion date: Jun 22, 2026 to Oct 22, 2026 · Completion date: Jun 21, 2028 to Oct 21, 2028v3 Show 2 more changesShow less
    • Primary completion date: Jun 22, 2026 to Oct 22, 2026
    • Completion date: Jun 21, 2028 to Oct 21, 2028
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UNICANCER
98 trials monitored
See 7 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
Esophageal Cancer
1,012 trials monitored
See 53 trials at risk
The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The main questions it aims to answer are: * Is this alternative chemotherapy option a better option in term of safety for this type of patients? * Does the combination of treatments improves the overall safety? * Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate? * Does the combination of treatment have an effect on quality of life? Participants will: * Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with: * Panitumumab or bevacizumab for colorectal adenocarcinomas * Nivolumab or trastuzumab for gastroesophageal adenocarcinomas. * Have a CT-Scan every 2 months until disease progression * Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months * Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis
Trial Details
NCT Number NCT06245356
Lead Sponsor UNICANCER
Collaborators: Servier
Conditions Metastatic Colorectal Cancer, Metastatic Gastroesophageal Adenocarcinoma, DPD Deficiency
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov